The Alzheimer's Association external quality control program for cerebrospinal fluid biomarkers.
The Alzheimer's Association external quality control program for cerebrospinal fluid biomarkers.
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DOI：
10.1016/j.jalz.2011.05.2243
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发表时间：
2011-07
期刊：
影响因子：
--
通讯作者：
Blennow K
中科院分区：
文献类型：
--
作者：
Mattsson N;Andreasson U;Persson S;Arai H;Batish SD;Bernardini S;Bocchio-Chiavetto L;Blankenstein MA;Carrillo MC;Chalbot S;Coart E;Chiasserini D;Cutler N;Dahlfors G;Duller S;Fagan AM;Forlenza O;Frisoni GB;Galasko D;Galimberti D;Hampel H;Handberg A;Heneka MT;Herskovits AZ;Herukka SK;Holtzman DM;Humpel C;Hyman BT;Iqbal K;Jucker M;Kaeser SA;Kaiser E;Kapaki E;Kidd D;Klivenyi P;Knudsen CS;Kummer MP;Lui J;Lladó A;Lewczuk P;Li QX;Martins R;Masters C;McAuliffe J;Mercken M;Moghekar A;Molinuevo JL;Montine TJ;Nowatzke W;O'Brien R;Otto M;Paraskevas GP;Parnetti L;Petersen RC;Prvulovic D;de Reus HP;Rissman RA;Scarpini E;Stefani A;Soininen H;Schröder J;Shaw LM;Skinningsrud A;Skrogstad B;Spreer A;Talib L;Teunissen C;Trojanowski JQ;Tumani H;Umek RM;Van Broeck B;Vanderstichele H;Vecsei L;Verbeek MM;Windisch M;Zhang J;Zetterberg H;Blennow K
脑脊液（CSF）生物标志物淀粉样蛋白β（Aβ）-42、总tau（T-tau）和磷酸化tau（P-tau）对阿尔茨海默病（AD）具有良好的诊断准确性。然而，研究之间、实验室之间和实验室内部的生物标志物测量存在很大差异。阿尔茨海默氏症协会已经启动了一项全球质量控制计划，以估计和监测测量的变异性，量化批次间的测定变异性，并确定变异性的来源。在这篇文章中，我们介绍了该计划前两轮的结果。该计划对使用市售Aβ、T-tau或P-tau试剂盒的实验室开放。CSF样本（合并CSF的等分试样）每年从瑞典哥德堡大学Molndal校区的临床神经化学实验室发送数次进行分析。每轮由三个质量控制样品组成。40个实验室参加。26例使用INNOTEST酶联免疫吸附测定试剂盒，14例使用Luminex xMAP和INNO-BIA AlzBio 3试剂盒（均测量Aβ-（1-42）、P-tau（181 P）和T-tau），5例使用Meso Scale Discovery和Aβ三链体（AβN-42、AβN-40和AβN-38）或T-tau试剂盒。实验室间的总变异系数为13%至36%。五个实验室在不同场合对样品进行了六次分析。实验室内精密度在各个实验室内的生物标志物之间差异很大。CSF AD生物标志物的测量结果显示实验室间变异性较大，可能由分析方法和分析试剂盒相关因素引起。实验室程序的标准化和试剂盒供应商提高试剂盒性能的努力可能会降低变异性，并可能增加CSF AD生物标志物的有用性。
The cerebrospinal fluid (CSF) biomarkers amyloid β (Aβ)-42, total-tau (T-tau), and phosphorylated-tau (P-tau) demonstrate good diagnostic accuracy for Alzheimer’s disease (AD). However, there are large variations in biomarker measurements between studies, and between and within laboratories. The Alzheimer’s Association has initiated a global quality control program to estimate and monitor variability of measurements, quantify batch-to-batch assay variations, and identify sources of variability. In this article, we present the results from the first two rounds of the program. The program is open for laboratories using commercially available kits for Aβ, T-tau, or P-tau. CSF samples (aliquots of pooled CSF) are sent for analysis several times a year from the Clinical Neurochemistry Laboratory at the Molndal campus of the University of Gothenburg, Sweden. Each round consists of three quality control samples. Forty laboratories participated. Twenty-six used INNOTESTenzyme-linked immunosorbent assay kits, 14 used Luminex xMAP with the INNO-BIA AlzBio3 kit (both measure Aβ-(1-42), P-tau(181P), and T-tau), and 5 used Meso Scale Discovery with the Aβ triplex (AβN-42, AβN-40, and AβN-38) or T-tau kits. The total coefficients of variation between the laboratories were 13% to 36%. Five laboratories analyzed the samples six times on different occasions. Within-laboratory precisions differed considerably between biomarkers within individual laboratories. Measurements of CSF AD biomarkers show large between-laboratory variability, likely caused by factors related to analytical procedures and the analytical kits. Standardization of laboratory procedures and efforts by kit vendors to increase kit performance might lower variability, and will likely increase the usefulness of CSF AD biomarkers.
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2.9
作者：
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